Positive Phase III Results Reported for Lanreotide (Somatuline) in Patients With Carcinoid Syndrome
Drug improves chances of treatment success versus placebo (January 17)
Results from the ELECT trial of lanreotide depot injection (Somatuline Depot, Ipsen) have been presented at the Gastrointestinal Cancers Symposium in San Francisco, California.
The 48-week phase III study assessed the effect of monthly lanreotide depot injection (120 mg) on the control of symptoms in patients with neuroendocrine tumors (NETs) associated with carcinoid syndrome. The study met its primary endpoint by demonstrating that the percentage of days in which octreotide was used as rescue medication during the 16-week double-blind phase was significantly lower in the lanreotide group than in the placebo group, representing a mean difference of –14.8% (P = 0.017).
In addition, a significantly greater proportion of patients in the lanreotide arm compared with the placebo arm experienced complete (40.7% vs. 23.2%, respectively) or partial (6.8% vs. 5.4%, respectively) treatment success. As a result, lanreotide significantly improved the chances of having either a complete or a partial treatment success versus placebo (odds ratio, 2.4; P = 0.036).
“Complete success” and “partial success” were defined, respectively, as no need for, or = 3 days of, use of octreotide as rescue medication between weeks 12 and 15. The need for more than 3 days of octreotide between weeks 12 and 15 was defined as treatment failure.
Lanreotide acetate is a somatostatin analogue that inhibits the secretion of several endocrine, exocrine, and paracrine functions. It has been shown to be effective in inhibiting the secretion of growth hormone and certain hormones secreted by the digestive system.
Somatuline Depot (lanreotide depot injection) is approved in the U.S. only for the treatment of acromegaly. Therefore, the clinical data reported in the ELECT trial reflect an investigational use of this product.
Source: Ipsen; January 17, 2014.